The China Food and Drug Administration's (CFDA) ("General Rules") will take effect on October 1, 2016. The General Rules elaborate on the official review requirements for food production licensing and expand on the requirements in its enabling regulation, the Management Rules for Food Production Licensing ("Management Rules"), which took effect the same time last year.
The General Rules are to be read together with the corresponding detailed rules for food production licensing review. CFSA also has issued an Official Q&A document relating to the General Rules that provides additional guidance for industry.Notably, the General Rules explicitly state that the provincial-level FDAs may formulate specific implementing rules for the management of food production licensing, and supplement/refine the "Scoring Table for On-site Inspection" as well as the "On-site Inspection Report" details. Thus, any potential applicant must first check with the provincial-level FDA and follow its specific requirements.
The General Rules provide a useful guide for ensuring compliance of domestic production facilities in China. Accordingly, we summarize certain of the more important requirements set forth in the General Rules below.
Scope: The General Rules detail the requirements for the review of production license applications for both food and food additives, as well as revisions and renewals thereof. With regard to "foods," these would include foods specially regulated in China (i.e., health foods, foods for special medical purposes (FSMPs), and formulated foods for infants and young children).
Application dossier: The food production licensing review covers both (1) an application dossier and (2) on-site inspection. General Rules provide that the application dossier should include the following documents:
- Application form*
- Photocopy of business license*
- General view of the food production processing site and its surrounding environment*
- General view of the layout of the functional areas of the food production processing site*
- General view of the layout of processing equipment
- Production process flow chart
- List of main equipment/facilities for food production*
- List of food safety management policies
- Other documents required by laws and regulations
For specially regulated foods (discussed in more detail below), production quality management system documentation as well as the corresponding product registration/notification also must be submitted. In addition, the General Rules provide that the application dossier for food additives must provide the information marked above (*), the layout of the main production equipment/facilities, as well as company policies to ensure the food additive's safety (e.g., safety self-evaluation policies, purchase inspection record policies, outgoing testing record policies, etc.). Again, provincial-level authorities may impose additional and/or more specific requirements, and should be consulted in advance of the application.
On-site Inspection: The General Rules provide for detailed requirements for the procedure and inspection items of the on-site inspection by first specifying the occasions when an on-site inspection is required. For example, an on-site inspection is mandatory when applying for a production license as well as when the changes in the production conditions may impact food safety at the time of renewal. Notably, an on-site inspection is necessary if the applicant's record shows non-compliance (e.g., at a supervisory spot-check/inspection, past food safety accident) or there are other potential problems in safeguarding food safety.
Specially Regulated Foods: China has established special regulatory requirements for foods that target special groups, including health foods, foods for special medical purpose (FSMPs) and formulated foods for infants and young children. Accordingly, the General Rules impose additional requirements for production licensing review where these specially regulated foods are involved. For example, as mentioned above, documentation for the production quality management system as well as the corresponding product registration/notification must be submitted in the application dossier.
Repackaging: The Official Q&A document makes it clear that repackaging is not allowed unless the detailed rules explicitly permit repackaging. For example, repackaging is permitted for chocolate but not infant formula. As a result, before applying for a food production license for repackaging, companies should confirm whether such repackaging is allowed for that particular food product in the first place.